Device Dossier
Pulse oximeter, battery-powered
Device Dossier for Pulse oximeter, battery-powered (Pulse oximeter, battery-powered, Class IIa, sponsor Genesis Biotech). ARTG record, intended purpose,…
- GMDN category: Pulse oximeter, battery-powered
Intended purpose
The pulse oximeter is intended to be used for noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric (≥10Kg) patients during both no motion and motion conditions, and for patients who are well or poorly perfused.